BISOPROLOL FUMARATE 2.5MG TABLETS

Transcript

1. What Cardicor is and what it is used for
The active substance in Cardicor is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines
work by affecting the body’s response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart
rate and makes the heart more efficient at pumping blood around the body.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s needs. Cardicor is used
to treat stable chronic heart failure.
It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides).
2. What you need to know before you take Cardicor
Do not take Cardicor
Do not take Cardicor if one of the following conditions applies to you:
• allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 ‘What Cardicor contains’)
• severe asthma or severe chronic lung disease
• severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to
tingle or turn pale or blue
• untreated phaeochromocytoma, which is a rare tumour of the adrenal gland
• metabolic acidosis, which is a condition when there is too much acid in the blood.

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Warnings and precautions
If you have any of the following conditions tell your doctor before taking Cardicor; he or she may want to take special care (for
example give additional treatment or perform more frequent checks):
• diabetes
• strict fasting
• certain heart diseases such as disturbances in heart rhythm, or severe chest pain at rest (Prinzmetal’s angina)
• kidney or liver problems
• less severe blood circulation problems in your limbs
• less severe asthma or chronic lung disease
• history of a scaly skin rash (psoriasis)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorder.

10/09/13
DATE OF PROOF:

UK PIL DATED MAY 2012

Do not take the following medicines with Cardicor without special advice from your doctor:
• certain medicines used to treat irregular or abnormal heartbeat (Class I antiarrhythmic medicines such as quinidine,
disopyramide, lidocaine, phenytoin; flecainide, propafenone)
• certain medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (calcium antagonists such as
verapamil and diltiazem)
• certain medicines used to treat high blood pressure such as clonidine, methyldopa, moxonodine, rilmenidine. However,
do not stop taking these medicines without checking with your doctor first.
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Other medicines and Cardicor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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Children and adolescents
Cardicor is not recommended for use in children or adolescents.

Cardicor 1.25mg 2.5mg tabs

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In addition, tell your doctor if you are going to have:
• desensitization therapy (for example for the prevention of hay fever), because Cardicor may make it more likely that you
experience an allergic reaction, or such reaction may be more severe
• anaesthesia (for example for surgery), because Cardicor may influence how your body reacts to this situation.

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CUSTOMER: Waymade

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Do not take Cardicor if you have one of the following heart problems:
• acute heart failure
• worsening heart failure requiring injection of medicines into a vein, that increase the force of contraction of the heart
• slow heart rate
• low blood pressure
• certain heart conditions causing a very slow heart rate or irregular heartbeat
• cardiogenic shock, which is an acute serious heart condition causing low blood pressure and circulatory failure.

Check with your doctor before taking the following medicines with Cardicor; your doctor may need to check your condition more
frequently:
• certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type calcium antagonists such as
felodipine and amlodipine)
• certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic medicines such as amiodarone)
• beta-blockers applied locally (such as timolol eye drops for glaucoma treatment)
• certain medicines used to treat for example Alzheimer’s disease or glaucoma (parasympathomimetics such as tacrine or
carbachol) or medicines that are used to treat acute heart problems (sympathomimetics such as isoprenaline and
dobutamine)
• antidiabetic medicines including insulin
• anaesthetic agents (for example during surgery)
• digitalis, used to treat heart failure
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, pain or inflammation (for example ibuprofen or
diclofenac)
• any medicine, which can lower blood pressure as a desired or undesired effect such as antihypertensives, certain
medicines for depression (tricyclic antidepressants such as imipramine or amitriptyline), certain medicines used to treat
epilepsy or during anaesthesia (barbiturates such as phenobarbital), or certain medicines to treat mental illness
characterized by a loss of contact with reality (phenothiazines such as levomepromazine)
• mefloquine, used for prevention or treatment of malaria
• depression treatment medicines called monoamine oxidase inhibitors (except MAO-B inhibitors) such as moclobemide.
Pregnancy and breast-feeding
There is a risk that use of Cardicor during pregnancy may harm the baby. If you are pregnant or planning to become pregnant, tell
your doctor. He or she will decide whether you can take Cardicor during pregnancy.
It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during therapy
with Cardicor.
Driving and using machines
Your ability to drive or use machinery may be affected depending on how well you tolerate the medicine. Please be especially
cautious at the start of treatment, when the dose is increased or the medication is changed, as well as in combination with alcohol.
3. How to take Cardicor
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Treatment with Cardicor requires regular monitoring by your doctor. This is particularly necessary at the start of treatment, during
dose increase, and when you stop treatment.
Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet.
The scored tablets can be divided into two equal doses.
Treatment with Cardicor is usually long-term.

What is in this leaflet:
1. What Cardicor is and what it is used for
2. What you need to know before you take Cardicor
3. How to take Cardicor
4. Possible side effects
5. How to store Cardicor
6. Contents of the pack and other information

PROOF HISTORY:
v.1 - waymade - 10/09/13

Leaflet Flat Size = 180 x 429

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is available in two different strengths, 1.25mg and 2.5mg and will be referred to as Cardicor throughout this leaflet.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

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Symptoms of an overdose may include slowed heart rate, severe difficulty in breathing, feeling dizzy, or trembling (due to
decreased blood sugar).
If you forget to take Cardicor
Do not take a double dose to make up for a forgotten dose. Take your usual dose the next morning.
If you stop taking Cardicor
Never stop taking Cardicor unless on your doctor’s advice. Otherwise your condition could become much worse.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred suddenly or gets worse rapidly.
The most serious side effects are related to the heart function:
• slowing of heart rate (affects more than 1 person in 10)
• worsening of heart failure (affects less than 1 person in 10)
• slow or irregular heartbeat (affects less than 1 person in 100)
If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.

Common (affects less than 1 person in 10):
• tiredness, feeling weak, dizziness, headache
• feeling of coldness or numbness in hands or feet
• low blood pressure
• stomach or intestine problems such as nausea, vomiting, diarrhoea, or constipation.

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Further side effects are listed below according to how frequently they may occur:

5. How to store Cardicor
Keep all medicines out of the sight and reach of children.
Do not use after the expiry date printed on the carton or blister strip after EXP. The expiry date refers to the last date of
that month.
Cardicor tablets should not be stored above 25°C.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to protect the environment.

These products are manufactured by Merck KGaA, Darmstadt, Germany and procured from within the EU and repackaged by the
Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex. SS14 3FR
Leaflet revision and issue date (Ref.) 10.09.2013
Cardicor is a registered trademark of Merck .

If you take more Cardicor than you should
If you have taken more Cardicor tablets than you should, tell your doctor immediately. Your doctor will decide what measures are
necessary.

PROOF HISTORY:
v.1 - waymade - 10/09/13

Leaflet Flat Size = 180 x 429

If you have to stop treatment entirely, your doctor will usually advise you to reduce the dose gradually, as otherwise your condition
may become worse.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time between dose increases. If
your condition gets worse or you no longer tolerate the drug, it may be necessary to reduce the dose again or to interrupt
treatment. In some patients a maintenance dose lower than 10 mg bisoprolol may be sufficient.
Your doctor will tell you what to do.

WARNING!

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Your doctor will decide how to increase the dose, and this will normally be done in the following way:
• 1.25 mg bisoprolol once daily for one week
• 2.5 mg bisoprolol once daily for one week
• 3.75 mg bisoprolol once daily for one week
• 5 mg bisoprolol once daily for four weeks
• 7.5 mg bisoprolol once daily for four weeks
• 10 mg bisoprolol once daily for maintenance (on-going) therapy.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Adults including the elderly
Treatment with bisoprolol must be started at a low dose and increased gradually.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.